Role at a glance
- Job function
-
Legal & Compliance Compliance & Regulatory Affairs
- Salary
- Not Disclosed
- Location
- Warsaw, PL
- Work arrangement
- Hybrid
- Employment
- Full-time
- Experience
- Senior Level Experience in regulatory submissions (typically 1–3+ years)
- Education
- Bachelor’s degree (science or related field preferred)
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Role Summary
Manages IND and global regulatory submissions from planning through delivery, coordinating across global teams to deliver compliant dossiers to health authorities. The role also supports consistency and continuous improvement across submission activities.
What You'll Do
- Coordinate submission activities with global teams and stakeholders, including submission strategy and timelines.
- Manage IND and marketing application submissions from planning through delivery.
- Track progress, risks, dependencies, and milestones across submission projects.
- Execute eCTD publishing and manage submissions through health authority portals; coordinate non-eCTD submissions with international teams.
- Maintain submission data, reporting, and tracking in Veeva RIM, and contribute to process improvement initiatives.
Generated from the employer's posting. Verify important details before applying.
View full postingQualifications
Experience in regulatory submissions; understanding of global regulatory requirements and submission processes; exposure to IND, eCTD, or global submissions; strong communication and stakeholder engagement skills; ability to manage priorities and deliver against timelines.
Preferred
- Science or related field for the bachelor’s degree
- Familiarity with Veeva RIM and the Lorenz docuBridge publishing tool
Original job description
Content provided by the employer
Original job description
Content provided by the employer
At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.
Shape How Medicines Reach Patients Worldwide
The Opportunity
What if your work didn’t just support submissions… but helped accelerate how innovative therapies reach patients across the globe?
At Bristol Myers Squibb, we’re transforming how regulatory submissions are delivered—making them faster, smarter, and globally aligned. As a Senior Specialist, you’ll play a critical role in driving high-quality submissions and improving how teams operate together globally.
Your Mission
Own and deliver IND and global regulatory submissions end-to-end, ensuring compliant, high-quality dossiers reach health authorities on time—while driving consistency, efficiency, and operational excellence across submission activities.
What Your Week Might Look Like
Leading coordination of submission activities across global teams
Partnering with stakeholders to define submission strategy and timelines
Managing IND and marketing application submissions from planning through to delivery
Tracking progress, identifying risks, and ensuring milestones stay on track
Executing eCTD publishing and managing submissions via HA portals
Working in Veeva RIM and Lorenz docubridge publishing tool to monitor, report, and manage content
What You’ll Do
Drive end-to-end submission management (IND and global applications)
Collaborate with cross-functional and global stakeholders to deliver compliant dossiers
Manage timelines, risks, and dependencies across submission projects
Execute and oversee eCTD publishing activities
Maintain submission data, reporting, and tracking in Veeva RIM
Coordinate non-eCTD submissions with international teams
Ensure consistency across submissions, studies, and regions
Contribute to continuous improvement and innovation initiatives
You’ll Thrive If You
Take ownership and proactively drive deliverables
Enjoy balancing coordination, execution, and problem-solving
Are confident working across global, matrixed environments
Have strong attention to detail and organisational skills
Are motivated to improve processes and embrace digital tools and automation
Your Background
Bachelor’s degree (science or related field preferred)
Experience in regulatory submissions (typically 1–3+ years)
Understanding of global regulatory requirements and submission processes
Exposure to IND, eCTD, or global submissions
Familiarity with tools such as Veeva RIM and Lorenze docuBridge publishing tool is a plus
Strong communication and stakeholder engagement skills
Ability to manage priorities and deliver against timelines
Why This Role is Different
Meaningful exposure to global regulatory submissions and health authorities
Opportunity to work across multiple regions and therapeutic areas
Strong visibility within regulatory and cross-functional teams
A chance to improve how submissions are delivered—at scale and with impact
Flexibility
Hybrid role with the option to work remotely up to 50% of the time, aligned with business and collaboration needs.
#LI-Hybrid
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
Compensation Overview:
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. The final compensation will be determined based on demonstrated experience and in accordance with pay equity principles and applicable employment laws.
How We Work
Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
Supporting People with Disabilities
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If this posting is missing required information required by local law or incorrect, contact BMS at [email protected] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.
R1601389 : Senior Specialist, Submission Management
About the company
Bristol Myers Squibb
Large Enterprise
Bristol Myers Squibb is a global biopharmaceutical company committed to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With a focus on oncology, immunology, and cardiovascular health, the company leverages advanced science and technology to create transformative therapies that address critical unmet medical needs. Operating in more than 70 countries, Bristol Myers Squibb emphasizes collaborative efforts and strong partnerships in research and development to drive advancements in healthcare and improve patient outcomes worldwide.